Russian Trial Rules Are A ‘Serious Blow’ To Pharma

Russian Trial Rules Are A ‘Serious Blow’ To Pharma

December 1st, 2011 // 1:28 pm @

There is nothing like a protectionist policy to slow things down. Take the Ethics Council at the Ministry of Healthcare and Social Development in Russia, which required drug sponsors to conduct local registration trials. Rather than provide a boost, the regulation “has become the most serious blow to the system governing the access of new medicines to the Russian pharmaceutical market over its entire recent history,” according to a trade group for clinical research organizations in Moscow.

Not only has the requirement upset drugmakers and clinical research organizations, but they are especially angered since a promised repeal from President Dmitry Medvedev never happened. “Last September, the government was supposed to draft a proposal to cancel local registration trials…However, so far there is no hope that the situation will change any time soon,” according to the quarterly latest report from the Association of Clinical Trial Organizations in Moscow, which was issued last week.

The complaint comes amid ongoing concern that multi-national drugmakers continue to have mixed feelings about conducting trials in Russia, since costs are lower; naive-treatment patients are more easily found; patients are more willing to follow protocol instructions, among other reasons. Moreover, costs are lower, although bureaucratic issues have been a recent issue. For instance, government approval of international multi-center trials in this year’s third quarter were below 2009 levels. Overall, trial approvals were down 13 percent in the recently ended quarter.

In order to reach at least the level of clinical trial approvals issued in 2010, ACTO reports that the Ministry of Healthcare and Social Development would have to issue at least 150 approvals in the fourth quarter of 2011. And the Ministry will only be able to attain 2009 levels if no fewer than 245 approvals are issued before the end of 2011, including 100 for international multi-center trials.

In making its argument that the government needs to move faster to abolish the requirement for local trials, the trade group notes that “repetitive trials involving humans without acute need are considered unethical,” and cites the World Medical Association Helsinki Declaration, which says ‘medical research involving human subjects may only be conducted if the importance of the objective outweighs the inherent risks and burdens to the research subjects.’ ”

ACTO underscores a few more reasons for moving quickly – by requiring local trials, the launch of new meds may be postponed by “several years” and certain multi-national drugmakers “will refuse to register new medicines in Russia if they decide that costs involved in local trials will not pay off or are prohibitively high.” And, the trade group notes, local studies should not be expected to provide any new information about a product.

And there is one more issue that ACTO raises. The requirement for local trials is causing ethical concerns, as well. The increased demand “has brought to life a number of service companies that specialise in this type of trials, but unfortunately, are not encumbered with high moral standards
and professionalism.”

“As long as developers and manufacturers of original and generic drugs are thrashing about the market trying to understand what they need to submit to the regulator in order to have their drug registered, new CRO’s have already appeared that are prepared to do fishing in troubled waters. For example, one such newly available CRO has sales events every month offering free development of a protocol, an investigator’s brochure, or a free trial approval from the Ministry of Healthcare and Social Development. Bona fide CRO’s who value their reputation prefer to avoid local trials”

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